The present invention relates to compression clips, and more specifically, to compression clips used to cause hemostasis of blood vessels located along the gastrointestinal tract.
Gastrointestinal (xe2x80x9cGIxe2x80x9d) bleeding is often associated with peptic ulcer disease and can be fatal if not treated immediately. For the estimated patient population of 10,000, approximately 2,000 will die during management of GI bleeding. This problem has prompted the development of a number of endoscopic therapeutic approaches to achieve hemostasis, such as the injection of sclerosing agents and contact thermo-coagulation techniques. Although such approaches are often effective, bleeding continues for many patients and emergency corrective surgery therefore becomes necessary. Because surgery is an invasive technique that is associated with many undesirable side effects, there exists the need for highly effective, less invasive procedures.
Mechanical hemostatic devices are used in various parts of the body, including GI applications. Such devices are typically in the form of clamps, clips, staples, sutures, etc., which are able to apply sufficient constrictive forces to blood vessels so as to limit or interrupt blood flow. One of the problems associated with conventional hemostatic devices, however, is that they are delivered using rigid-shafted instruments via incision or trocar cannula. Moreover, conventional endoscopic hemostatic devices are not generally strong enough to consistently control GI bleeding.
The present invention provides medical devices and methods of deploying such medical devices for causing the hemostasis of blood vessels located along the gastrointestinal tract. Each of the medical devices of the present invention comprises a clip that includes a stem having a first end and a second end; an anchor at the first end of the stem; and a bolster at or near the second end of the stem. In one embodiment of the invention, the stem has at least one transverse hole therein, and the bolster is slidable about the stem and includes a flap adapted to be inserted into the transverse hole. In a second embodiment of the invention, the stem has at least one engaging member extending therefrom, and the bolster has a central opening that is wider than the stem at a location where the engaging member is absent but is more narrow than the stem at a location where the engaging member is present. In a third embodiment of the invention, the stem has at least one dimple therein and the bolster has at least one locking element attached thereto by a spring, wherein the locking element fits within the dimple. In a fourth embodiment of the invention, the bolster is fixed at the second end of the stem.
One advantage of the present invention is that it provides a medical device that, when deployed, creates sufficient tissue compression to hemostatically control GI bleeding.
Another advantage of the present invention is that it provides a consistent, reproducible means for controlling GI bleeding.
Another advantage of the present invention is that it provides a definitive solution to the problem of GI bleeding.
Yet another advantage of the present invention is that it provides a means to control GI bleeding without resorting to open or laparoscopic surgical techniques.